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XenoMem™ Wound Matrix is indicated for the management of wounds including:

• · Partial and full-thickness wounds;
• · Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers;
• · Tunnelled/undermined wounds
• · Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound deliscence),
• · Trauma wounds (abrasions, lacerations, second-degree burns, skin tears);
• Draining wounds.

XenoMem™ Wound Matrix is an acellular, porcine peritoneal matrix, supplied sterile to maintain and support an environment for wound management. It consists of an extracellular tissue matrix, derived from porcine peritoneum. XenoMem™ Wound Matrix porcine peritoneal membrane provides a robust biological matrix that allows for easier handling during preparation and application of the wound dressing. The membrane has undergone a decellularisation, viral inactivation and a freeze-drying process in order to remove donor genetic material, in a non-destructive manner, so as to maintain the structure and function of the tissue. XenoMem is sterilized via gamma irradiation and sold for prescription only.

The provided text describes the 510(k) summary for the XenoMem™ Wound Matrix device, focusing on its substantial equivalence to predicate devices rather than a study proving the device meets specific performance acceptance criteria for a new clinical claim. This document is a regulatory submission for market clearance based on comparing the new device to existing legally marketed devices.

Therefore, the information requested in your prompt regarding acceptance criteria for a new clinical claim, a study that proves it, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies is not available in the provided text.

The closest information available is a "Summary of Testing and Results Supporting Substantial Equivalence," which describes various bench and analytical tests performed to show that the XenoMem™ Wound Matrix is comparable to its predicate device (Oasis® Wound Matrix).

Here's the information that can be extracted from the provided text, reformatted to align with your request, and highlighting the missing elements:

1. A table of acceptance criteria and the reported device performance

Important Note: These are not performance acceptance criteria for a clinical claim in the traditional sense, but rather a list of tests conducted to support the claim of substantial equivalence to a predicate device for regulatory clearance. The "met requirements" indicates the device performed comparably to the predicate or within predefined industry standards for these specific properties.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not available. The document does not describe specific "test sets" or clinical studies with human participants that would typically have sample sizes and data provenance details. The tests listed are primarily bench (in vitro) and analytical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not available. No ground truth establishment by external experts is described for these bench and analytical tests. The "ground truth" for these tests would be the established scientific methods and acceptable ranges for each parameter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not available. No adjudication method is described as this document pertains to laboratory and analytical testing for substantial equivalence, not a clinical study requiring human interpretation or consensus.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not available. This device is a wound matrix, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not available. As above, this is a physical medical device (wound matrix), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the tests listed (tensile strength, thickness, residual DNA, sterility, biocompatibility, DSC, etc.), the "ground truth" would be established scientific and engineering standards, ISO standards, and relevant FDA guidance documents for medical device materials and manufacturing. This is not "expert consensus" or clinical outcomes data in the context of diagnostic performance.

8. The sample size for the training set

• Not applicable/Not available. No "training set" is described as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not applicable/Not available. No training set is described.

In summary, the provided document is an FDA 510(k) clearance letter and summary for a physical medical device (wound matrix). It demonstrates substantial equivalence based on material properties, manufacturing processes, and safety testing, as opposed to a clinical study proving new diagnostic or treatment efficacy claims with specific acceptance criteria that would involve human experts, large test sets, or AI performance metrics.

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Meso Tendon Matrix is indicated for use in sports medicine procedures for the reinforcement and repair of soft tissue where weakness exists including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons. Meso Tendon Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. Meso Tendon Matrix is supplied sterile and for one time use.

Meso Tendon Matrix is a resorbable surgical mesh intended to reinforce soft tissue where weakness exists. The implant is derived from porcine mesothelium tissue. The material is supplied sterile in double-layer packages. The implant is packaged dry and prior to use is hydrated with saline or autologous body fluids such as blood, bone marrow aspirate, or blood concentrates such as platelet rich plasma.

Here's an analysis of the acceptance criteria and supporting studies for the Meso Tendon Matrix device, based on the provided text:

This document is a 510(k) summary for a medical device (Meso Tendon Matrix) seeking substantial equivalence to a predicate device (Medeor Matrix). The acceptance criteria are primarily demonstrated through equivalence to the predicate, rather than meeting specific performance thresholds against a diagnostic "ground truth" as would be the case for a diagnostic AI device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Biocompatibility: The text does not specify the sample size for each test conducted under ISO 10993-1:2009. These typically involve standardized protocols where sample size is determined by the specific test method (e.g., number of cell cultures, animals per group).
• Biomechanical Testing: Not specified.
• Animal Implant Studies: Not specified.
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing and studies conducted by DSM Biomedical or contracted testing facilities. Given the nature of these tests, it's prospective testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of device (surgical mesh) does not involve a "ground truth" established by experts in the sense of a diagnostic interpretation (e.g., radiologists reviewing images). Instead, acceptance criteria are based on objective, standardized scientific and engineering tests (biocompatibility, mechanical properties) and animal model outcomes for tissue response. The "ground truth" is established by the validated methods of these scientific tests themselves and the comparison to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations. The "adjudication" is essentially the comparison of the test results to predefined acceptance criteria or to the predicate device's characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI or diagnostic imaging device. An MRMC study is not relevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in the sense that the device's inherent properties (biocompatibility, mechanical strength, in vivo tissue response) were tested independently without a "human-in-the-loop" component. The device itself is not an algorithm, so this question is interpreted as the device's performance being evaluated in a standalone manner.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance is established through:

• Compliance with International Standards: For biocompatibility, adherence to ISO 10993-1:2009.
• Objective Engineering Measurements: For biomechanical properties (tensile strength, burst, tear, suture retention).
• Observed Biological Response: In animal implant studies, observing normal tissue healing and remodeling.
• Comparison to Predicate Device: The primary "ground truth" for regulatory clearance is substantial equivalence to the Medeor Matrix (K103787) across material, intended use, principles of operation, and technological characteristics.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm requiring a training set. The "training" in a broad sense would be the research and development phase where materials were selected and manufacturing processes optimized, but this is not a data-driven "model training" process.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as above.

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Meso Wound Matrix is a resorbable porcine mesothelium derived product intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears), and draining wounds.

The device is intended for one time use.

Meso Wound Matrix is composed of porcine collagen from peritoneum tissue. It is an absorbent, white to off- white material supplied as sheet. The device is packaged sterile in a double-layer package.

The provided text is a 510(k) summary for the Meso Wound Matrix and an FDA letter confirming substantial equivalence. It does not present a study or acceptance criteria for device performance as typically understood for AI/software-as-a-medical-device (SaMD) products. Instead, it focuses on the device's technological characteristics, biocompatibility, and substantial equivalence to a predicate device based on regulatory requirements for a wound dressing.

Therefore, many of the requested items, such as acceptance criteria table with reported performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone performance, are not applicable or available in this document. This document is related to a traditional medical device (wound dressing), not an AI/SaMD product.

However, I can extract information relevant to the regulatory approval process as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance metrics for the device's efficacy in terms of wound healing. The "performance data" section rather lists types of tests conducted for regulatory compliance.

   Acceptance Criteria Category	Reported Device Performance (Summary)
   Biocompatibility	Passed tests according to ISO 10993-1:2003
   	- Cytotoxicity
   	- Sensitization
   	- Systemic Toxicity
   	- Sub-Chronic Toxicity
   	- Genotoxicity
   	- Implantation
   	- Pyrogenicity
   	- Hemocompatibility
   Hydration	Testing conducted; no specific results or criteria provided
   Animal Testing	Testing conducted; no specific results or criteria provided
   Viral Inactivation	Testing conducted; no specific results or criteria provided
   Technological Characteristics	"Technologically identical to the cleared KN ECM Surgical Patch (K094061)"
   Material	Composed of porcine collagen from peritoneum tissue
   Sterility	Packaged sterile

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/SaMD product with a "test set" in the context of algorithm evaluation. The document mentions "animal testing" but does not specify sample sizes or provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm's performance is not relevant for this type of device submission. Regulatory decisions are based on the demonstrated characteristics and equivalence to predicate devices, assessed by FDA reviewers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the "Performance Data" sections (biocompatibility, hydration, animal, viral inactivation), the "ground truth" would be the established scientific and regulatory standards for each test type (e.g., specific endpoints for biocompatibility, histological findings in animal studies, viral load reduction for inactivation studies). No single "ground truth" like pathology or outcomes data is explicitly detailed here for a classification task. The primary ground for approval is Substantial Equivalence to a legally marketed predicate device, based on material, intended use, and technological characteristics.

8. The sample size for the training set: Not applicable. This is not an AI/ML product that uses a "training set."

9. How the ground truth for the training set was established: Not applicable. No training set is involved.

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